NCT06564194

A Phase 1 Randomized, Double-Blinded Study to Assess the Safety, Reactogenicity and Immunogenicity of JCXH-108, an mRNA-based Investigational Vaccine Against Respiratory Syncytial Virus (RSV) in Healthy Subjects ≥ 60 Years of Age and 18-45 Years of Age

Active, enrolled Phase 1 Last updated 21 April 2026

What this trial tests

Phase 1 trial testing JCXH-108 in Respiratory Syncytial Virus (RSV) in 75 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

25 September 2024

Primary endpoint
1 June 2026

1 June 2026

Quick facts

Lead sponsor	Immorna Biotherapeutics, Inc.
Phase	Phase 1
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	75
Start date	25 September 2024
Primary completion	1 June 2026
Estimated completion	1 June 2026
Sites	3 locations across United States

Drugs / interventions tested

• JCXH-108 — full drug profile →
• Placebo

Conditions studied

• Respiratory Syncytial Virus (RSV) — all drugs for Respiratory Syncytial Virus (RSV) →
• Infectious Disease — all drugs for Infectious Disease →

Sponsor

Immorna Biotherapeutics, Inc. — full company profile →

Who can join

18 and older, any sex, with Respiratory Syncytial Virus (RSV) or Infectious Disease. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• SAE Frequency
  Time frame: Day 1 - Day 180 (6 Months)
  Frequency of SAEs characterized by type, severity, duration, and relationship to the JCXH-108 recorded from Day 1 (D1) post-vaccine administration through follow-up completion.
• Injection site reaction
  Time frame: Day 1 - Day 30
  Solicited local injection site reactions characterized by frequency, severity, and duration recorded within 30 days after administration after vaccine administration (JCXH-108 or Placebo)
• Solicited systemic reaction frequency
  Time frame: Day 1 - Day 30
  Solicited systemic adverse reactions characterized by frequency, severity, and duration recorded within 30 days after vaccine administration (JCXH-108 or Placebo)
• AE frequency
  Time frame: Day 1 -Day 30
  Adverse events (AEs) including unsolicited AEs characterized by type, severity, duration, and relationship to the vaccine (JCXH-108 or Placebo) recorded from Day 1 post-vaccine administration to within 30 days following vaccine administration
• Medically attended AE frequency
  Time frame: Day 1 - Day 180 (6 Months)
  Medically attended AEs (MAAEs) characterized by frequency, severity, duration, and relationship to the vaccine (JCXH-108 or Placebo) recorded from Day 1 post-vaccine administration (JCXH-108 or Placebo) through follow-up completion
• Potential immune-mediated adverse events frequency
  Time frame: Day 1 - Day 180 (6 Months)
  Potential immune-mediated disease (pIMDs) characterized by frequency, severity, duration, and relationship to the vaccine (JCXH-108 or Placebo) recorded from Day 1 post-vaccine administration (JCXH-108 or Placebo) through follow-up completion

Sponsor's own description

The goal of this clinical trial is to assess the safety, reactogenicity and immunogenicity of an mRNA-based vaccine, JCXH-108, the prevention of Respiratory Syncytial Virus (RSV) infection and diseases.

Participants will be randomized to receive either JCXH-108 or placebo.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Design Strategies for Novel Lipid Nanoparticle for mRNA Vaccine and Therapeutics: Current Understandings and Future Perspectives.
   Li X, Li J, Wei J, Du W, et al · · 2025 · cited 7× · PMID 41059491 · DOI 10.1002/mco2.70414
2. A Systematic Review of Clinical Trials Using mRNA Vaccines for Infectious Diseases other than COVID-19.
   Sofroniou A, Ridley A. · · 2025 · cited 2× · PMID 40756606 · DOI 10.3389/bjbs.2025.14557
3. Exploring Therapeutic Targets From Spreading Patterns Against Respiratory Syncytial Virus.
   Zhang H, Zhang Z, Yang Y, Pei J. · · 2025 · cited 2× · PMID 40689767 · DOI 10.1096/fj.202500509rr
4. mRNA Vaccine Technology Beyond COVID-19.
   Oloruntimehin S, Akinyi F, Paul M, Ariyo O. · · 2025 · cited 2× · PMID 40573932 · DOI 10.3390/vaccines13060601
5. Respiratory virus mRNA vaccines: mRNA Design, clinical studies, and future challenges.
   Zheng L, Feng H. · · 2025 · cited 2× · PMID 40469015 · DOI 10.1002/ame2.70018
6. Deciphering the biological fate of mRNA-LNP-based biologics: A perspective from tissue to intracellular distribution.
   Xu X, Cui L, Zhang Y, Gu J. · · 2026 · cited 1× · PMID 42039274 · DOI 10.1016/j.apsb.2025.11.023
7. Delivery Systems of mRNA Vaccines in the Treatment of Infectious Diseases: From Lipid Nanoparticles to Next-Generation Platforms.
   Hsu CY, Abdulazez AA, Almajidi YQ, Kareem AK, et al · · 2025 · PMID 41835055 · DOI 10.34172/apb.025.46087
8. Respiratory Syncytial Virus (RSV): A Comprehensive Overview From Basic Biology to Clinical Prevention and Control.
   Shi J, Huang X, Ye C, Lu Y, et al · · 2026 · PMID 41261734 · DOI 10.1002/med.70025